Results Summary



Target vs. Comparator ~ Outcome [Analysis, DB]:

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,688 17,132 13,110 22,949 115 149 8.77 6.49 1.43
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 187 209 312 753 937 2,177
Comparator 2 207 235 344 826 1,030 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,688 17,132 13,107 22,933 99 184 7.55 8.02 1.41
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 188 209 312 752 935 2,177
Comparator 5 207 235 343 824 1,029 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
7,658 7,658 20,963 20,704 195 175 9.30 8.45 1.34
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 202 474 969 1,731 1,862 2,188
Comparator 11 196 458 936 1,712 1,847 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
7,658 7,658 20,992 20,643 176 198 8.38 9.59 1.34
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 202 475 972 1,733 1,863 2,188
Comparator 8 194 453 935 1,710 1,840 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
7,660 7,660 9,627 9,363 64 73 6.65 7.80 1.61
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 14 203 209 315 774 976 2,177
Comparator 8 182 220 322 741 916 2,184
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
7,660 7,660 9,638 9,359 74 73 7.68 7.80 1.59
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 203 209 315 775 976 2,177
Comparator 2 182 221 322 742 914 2,184
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,688 17,132 28,205 54,618 265 454 9.40 8.31 1.24
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 188 445 907 1,697 1,833 2,189
Comparator 5 265 614 1,221 1,911 2,029 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,688 17,132 28,176 54,714 277 421 9.83 7.69 1.24
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 188 441 902 1,698 1,833 2,189
Comparator 2 270 620 1,222 1,911 2,029 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
7,665 7,665 9,649 9,282 78 67 8.08 7.22 1.59
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 201 209 315 777 975 2,177
Comparator 9 181 222 320 732 897 2,177
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
7,665 7,665 9,638 9,275 70 81 7.26 8.73 1.58
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 201 209 315 776 972 2,177
Comparator 5 180 220 319 731 898 2,177
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,688 17,132 13,110 22,949 115 149 8.77 6.49 1.43
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 187 209 312 753 937 2,177
Comparator 2 207 235 344 826 1,030 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,688 17,132 13,107 22,933 99 184 7.55 8.02 1.41
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 188 209 312 752 935 2,177
Comparator 5 207 235 343 824 1,029 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
7,667 7,667 21,155 20,635 193 178 9.12 8.63 1.34
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 209 480 984 1,733 1,862 2,188
Comparator 11 193 452 935 1,707 1,841 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
7,667 7,667 21,158 20,602 191 192 9.03 9.32 1.33
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 209 481 986 1,733 1,862 2,188
Comparator 5 191 448 934 1,708 1,841 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,688 17,132 28,176 54,714 277 421 9.83 7.69 1.24
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 188 441 902 1,698 1,833 2,189
Comparator 2 270 620 1,222 1,911 2,029 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Etanercept (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,688 17,132 28,205 54,618 265 454 9.40 8.31 1.24
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 188 445 907 1,697 1,833 2,189
Comparator 5 265 614 1,221 1,911 2,029 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Etanercept (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,454 20,386 12,847 25,958 117 183 9.11 7.05 1.41
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 188 209 312 754 943 2,177
Comparator 4 207 232 333 777 970 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,454 20,386 12,850 25,924 97 189 7.55 7.29 1.42
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 189 209 312 754 941 2,177
Comparator 2 207 232 332 776 969 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
8,216 8,216 22,084 21,878 213 203 9.64 9.28 1.32
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 196 462 931 1,711 1,848 2,188
Comparator 4 180 441 931 1,693 1,838 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
8,216 8,216 22,112 21,879 200 193 9.04 8.82 1.33
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 199 466 937 1,707 1,846 2,188
Comparator 2 182 441 928 1,695 1,840 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
8,210 8,210 10,198 9,704 93 82 9.12 8.45 1.53
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 194 209 315 770 950 2,177
Comparator 4 174 212 312 707 878 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
8,210 8,210 10,203 9,684 75 82 7.35 8.47 1.56
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 194 209 314 770 949 2,177
Comparator 2 174 212 312 706 877 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,454 20,386 27,779 60,382 276 455 9.94 7.54 1.24
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 189 447 915 1,705 1,838 2,189
Comparator 4 231 550 1,098 1,797 1,952 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,454 20,386 27,803 60,337 263 449 9.46 7.44 1.25
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 192 451 920 1,704 1,838 2,189
Comparator 2 230 547 1,097 1,798 1,952 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
8,210 8,210 10,153 9,644 78 79 7.68 8.19 1.56
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 195 209 313 761 946 2,177
Comparator 15 179 213 313 706 874 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
8,210 8,210 10,153 9,649 88 88 8.67 9.12 1.53
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 195 209 313 762 946 2,177
Comparator 4 175 213 313 707 876 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,454 20,386 12,847 25,958 117 183 9.11 7.05 1.41
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 188 209 312 754 943 2,177
Comparator 4 207 232 333 777 970 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,454 20,386 12,850 25,924 97 189 7.55 7.29 1.42
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 189 209 312 754 941 2,177
Comparator 2 207 232 332 776 969 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
8,211 8,211 22,105 22,110 214 186 9.68 8.41 1.32
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 199 461 938 1,712 1,845 2,188
Comparator 4 180 447 944 1,715 1,858 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
8,211 8,211 22,134 22,086 203 182 9.17 8.24 1.33
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 200 464 942 1,712 1,845 2,188
Comparator 7 179 446 942 1,718 1,861 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,454 20,386 27,779 60,382 276 455 9.94 7.54 1.24
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 189 447 915 1,705 1,838 2,189
Comparator 4 231 550 1,098 1,797 1,952 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RCT) vs. Adalimumab (RCT) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
10,454 20,386 27,803 60,337 263 449 9.46 7.44 1.25
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 10 192 451 920 1,704 1,838 2,189
Comparator 2 230 547 1,097 1,798 1,952 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RCT)) and comparator (Adalimumab (RCT)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
34,961 71,261 43,059 97,478 286 412 6.64 4.23 1.25
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 186 209 313 753 943 2,189
Comparator 2 207 235 348 848 1,062 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Stroke (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
34,961 71,261 43,042 97,443 265 453 6.16 4.65 1.25
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 186 209 313 753 943 2,189
Comparator 1 207 235 348 849 1,062 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
26,474 26,474 74,886 72,547 506 506 6.76 6.97 1.19
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 195 476 1,025 1,791 1,915 2,190
Comparator 2 165 447 963 1,748 1,908 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
26,474 26,474 74,886 72,520 497 483 6.64 6.66 1.20
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 196 476 1,025 1,788 1,914 2,190
Comparator 2 165 446 963 1,748 1,909 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
26,465 26,465 32,899 32,099 203 180 6.17 5.61 1.33
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 192 209 313 761 959 2,189
Comparator 2 167 209 317 736 912 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Stroke (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
26,465 26,465 32,891 32,075 187 197 5.69 6.14 1.33
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 192 209 313 761 961 2,189
Comparator 2 166 209 316 735 914 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
34,961 71,261 96,598 239,487 699 1,196 7.24 4.99 1.15
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 187 459 979 1,767 1,896 2,190
Comparator 2 273 668 1,309 1,994 2,091 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
34,961 71,261 96,529 239,321 686 1,188 7.11 4.96 1.15
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 187 459 978 1,763 1,895 2,190
Comparator 1 272 665 1,308 1,995 2,091 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Stroke (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
26,450 26,450 32,793 31,940 189 202 5.76 6.32 1.33
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 193 209 313 756 953 2,189
Comparator 2 165 209 317 733 906 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
26,450 26,450 32,799 31,969 202 184 6.16 5.76 1.33
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 193 209 314 756 953 2,189
Comparator 2 166 209 317 733 906 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
34,961 71,261 43,059 97,478 286 412 6.64 4.23 1.25
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 186 209 313 753 943 2,189
Comparator 2 207 235 348 848 1,062 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Stroke (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
34,961 71,261 43,042 97,443 265 453 6.16 4.65 1.25
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 186 209 313 753 943 2,189
Comparator 1 207 235 348 849 1,062 2,189
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
26,459 26,459 74,875 72,553 507 491 6.77 6.77 1.19
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 196 479 1,026 1,785 1,911 2,190
Comparator 2 166 441 966 1,743 1,909 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
26,459 26,459 74,906 72,644 512 504 6.84 6.94 1.19
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 195 479 1,026 1,789 1,915 2,190
Comparator 2 166 445 968 1,746 1,910 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
34,961 71,261 96,598 239,487 699 1,196 7.24 4.99 1.15
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 187 459 979 1,767 1,896 2,190
Comparator 2 273 668 1,309 1,994 2,091 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. [TOFA]_RWD_ETN_0208version ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
34,961 71,261 96,529 239,321 686 1,188 7.11 4.96 1.15
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 187 459 978 1,763 1,895 2,190
Comparator 1 272 665 1,308 1,995 2,091 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator ([TOFA]_RWD_ETN_0208version) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
34,087 84,210 42,037 107,815 279 475 6.64 4.41 1.25
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 189 209 313 753 943 2,189
Comparator 1 207 235 335 771 966 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
34,087 84,210 42,027 107,767 254 499 6.04 4.63 1.25
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 2 189 209 313 753 943 2,189
Comparator 2 207 235 335 770 966 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
27,388 27,388 76,492 75,418 516 541 6.75 7.17 1.19
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 192 466 1,001 1,776 1,904 2,190
Comparator 1 167 444 976 1,761 1,917 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
27,388 27,388 76,437 75,430 509 513 6.66 6.80 1.19
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 2 192 466 1,000 1,775 1,903 2,190
Comparator 3 167 444 976 1,760 1,916 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
27,393 27,393 33,761 32,370 215 205 6.37 6.33 1.31
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 189 209 312 753 945 2,189
Comparator 1 173 222 316 702 865 2,188
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [On Treatment (Matching) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
27,393 27,393 33,764 32,350 186 213 5.51 6.58 1.32
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 2 190 209 312 753 946 2,189
Comparator 2 173 222 315 701 865 2,188
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
34,087 84,210 94,965 259,322 690 1,259 7.27 4.85 1.15
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 192 465 991 1,775 1,904 2,190
Comparator 1 240 577 1,169 1,876 2,005 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
34,087 84,210 94,899 259,223 671 1,253 7.07 4.83 1.15
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 2 192 465 991 1,771 1,903 2,190
Comparator 2 238 574 1,169 1,876 2,005 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
27,372 27,372 33,741 32,278 184 213 5.45 6.60 1.32
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 6 193 209 312 753 945 2,189
Comparator 3 172 221 315 701 871 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
27,372 27,372 33,739 32,306 203 204 6.02 6.31 1.32
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 193 209 312 753 945 2,189
Comparator 1 172 221 315 702 872 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
34,087 84,210 42,037 107,815 279 475 6.64 4.41 1.25
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 189 209 313 753 943 2,189
Comparator 1 207 235 335 771 966 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [On Treatment (Stratification) - Original Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
34,087 84,210 42,027 107,767 254 499 6.04 4.63 1.25
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 2 189 209 313 753 943 2,189
Comparator 2 207 235 335 770 966 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
27,372 27,372 76,466 75,012 513 515 6.71 6.87 1.19
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 6 194 468 1,001 1,771 1,902 2,190
Comparator 3 173 445 966 1,749 1,904 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Matching) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
27,372 27,372 76,508 75,102 511 514 6.68 6.84 1.19
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 194 468 1,004 1,775 1,903 2,190
Comparator 1 173 445 969 1,753 1,907 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Acute Myocardial Infarction (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
34,087 84,210 94,965 259,322 690 1,259 7.27 4.85 1.15
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 1 192 465 991 1,775 1,904 2,190
Comparator 1 240 577 1,169 1,876 2,005 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier

Tofacitinib (RWD) vs. Adalimumab (RWD) ~ Stroke (LEGEND Version) [Intent-to-Treat (Stratification) - New Exclusion Covariates, Open Claims]

Power

Target subjects Comparator subjects Target years Comparator years Target events Comparator events Target IR (per 1,000 PY) Comparator IR (per 1,000 PY) MDRR
34,087 84,210 94,899 259,223 671 1,253 7.07 4.83 1.15
Table 1a. Number of subjects, follow-up time (in years), number of outcome events, and event incidence rate (IR) per 1,000 patient years (PY) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after propensity score adjustment, as well as the minimum detectable relative risk (MDRR). Note that the IR does not account for any stratification.


Cohort Min P10 P25 Median P75 P90 Max
Target 2 192 465 991 1,771 1,903 2,190
Comparator 2 238 574 1,169 1,876 2,005 2,190
Table 1b. Time (days) at risk distribution expressed as minimum (min), 25th percentile (P25), median, 75th percentile (P75), and maximum (max) in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) cohort after propensity score adjustment.


Attrition

Figure 1. Attrition diagram, showing the Number of subjectsin the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group after various stages in the analysis.

Population Characteristics

Table 2. Select characteristics before and after propensity score adjustment, showing the (weighted) percentage of subjects with the characteristics in the target (Tofacitinib (RWD)) and comparator (Adalimumab (RWD)) group, as well as the standardized difference of the means.


Propensity Scores

Figure 2. Preference score distribution. The preference score is a transformation of the propensity score that adjusts for differences in the sizes of the two treatment groups. A higher overlap indicates subjects in the two groups were more similar in terms of their predicted probability of receiving one treatment over the other.

Covariate Balance


Systematic Error

Figure 4. Systematic error. Effect size estimates for the negative controls (true hazard ratio = 1) and positive controls (true hazard ratio > 1), before and after calibration. Estimates below the diagonal dashed lines are statistically significant (alpha = 0.05) different from the true effect size. A well-calibrated estimator should have the true effect size within the 95 percent confidence interval 95 percent of times.


Kaplan-Meier